A homoeopathic medicinal product is a medicinal product prepared from substances named as homoeopathic substances in accordance with the homoeopathic preparation procedure and according to the provisions of European Pharmacopoeia or according to the current pharmacopoeia of European Union member states if European Pharmacopoeia does not contain such provisions.
Obtaining of marketing authorisation:
In Slovenia, homoeopathic medicinal products for veterinary use may obtain marketing authorisation:
- by normal procedure for medicinal products (in accordance with Article 44 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14) if the medicinal product is presented as having healing effects for individual therapeutic indication;
- by simplified procedure (in accordance with Article 53 of the Medicinal Products Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 17/14) in which the applicant does not need to submit clinical documentation about the homoeopathic medicinal product if it meets the following conditions:
- it is for oral or external use only;
- does not include therapeutic effects or therapeutic indications or information on the packaging or in package leaflet which relate to them;
- has an adequate dilution degree to assure safety: it may not contain more than 1 part of the mother tincture per 10,000 parts of solvent or carrier agent.
Application for registration of homoeopathic medicinal products must include:
– cover letter
– completed application form for registration of homoeopathic medicinal products (under preparation)
– documentation for registration of homoeopathic medicinal products,
The procedure of obtaining marketing authorisation for homoeopathic medicinal products may be done under the national procedure, the mutual recognition procedure or the decentralised procedure, in accordance with the Medicinal Products Act and Rules on marketing authorisation for medicinal products in veterinary use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 16/11).
Fees regarding issuing, amending, extending, transferring and termination of marketing authorisation for homoeopathic medicinal products are stated in Article 19 of Rules on fees in medicinal products (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 16/11).
Labelling:
Homoeopathic medicinal products for veterinary use must be labelled in accordance with the provisions of Rules on labelling and package leaflet for medicinal products in veterinary use (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 101/09; Medicinal Products Act (17/14 – ZZdr-2)), and the label must clearly show the text “homoeopathic medicinal product for veterinary use”.
Advertising:
Homoeopathic medicinal products for veterinary use may be advertised in accordance with the Medicinal product Advertising Act (Official Gazette of the Republic of Slovenia [Uradni list RS], No. 105/08, 105/10; Medicinal Products Act 17/14 – ZZdr-2).
Instructions of Homeopathic Medicinal Products Working Group (HMPWG) www.hma.eu/380.html
